A Trial to Evaluate the Efficacy and Safety of Methoxyethyl Etomidate Hydrochloride in Gastroscopy/Colonoscopy

Phase 2

Not yet recruiting

• Conditions: Gastroscopy; Colonoscopy
• Interventions: Drug: Etomidate Injectable Product 0.3mg/kg group; Drug: ET-26HCl 0.6mg/kg group; Drug: ET-26HCl 0.8mg/kg group

• Registration Number: NCT06682546
• Lead Sponsor: Ahon Pharmaceutical Co., Ltd.

Brief Summary

A total of 78 subjects undergoing gastroscopy/colonoscopy were randomly assigned to the methoxetomidate hydrochloride group and the etomidate group according to the ratio of 1:1:1 with etomidate as the control group, 26 cases in each group. All subjects were blinded to treatment allocation. Screening assessments for all subjects will be completed within D-14 to D-2 before the first dose. For all subjects who received the investigational drug, they were required to return to the research center on D2-5 to complete the corresponding examination before being discharged from the group. To preliminarily evaluate the efficacy and safety of ET-26 in gastroscopy/colonoscopy.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-07
• Study First Submitted QC: 2024-11-08
• Last Update Submitted: 2024-11-08
• Study First Posted: 2024-11-11
• Last Update Posted: 2024-11-11
• Study Start: 2024-11-15
• Primary Completion: 2025-03-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

1. patients undergoing routine gastroscopy/colonoscopy with an expected gastroscopy/colonoscopy procedure time of less than 20 minutes;
2. age ≥ 18 and ≤ 75 years old, regardless of gender;
3. American Society of Anesthesiologists (ASA) grade I-III;
4. Body mass index (BMI) 18-30 kg/m2 (including the cut-off value) and body weight ≤100 kg;
5. Vital signs during screening: respiratory rate ≥10 and ≤24 times/min; Pulse oxygen saturation (SpO2) ≥95% while breathing air; Systolic blood pressure (SBP) ≥90mmHg and ≤160mmHg; Diastolic blood pressure (DBP) ≥60mmHg and ≤100mmHg; Heart rate (ECG) ≥55 and ≤100 beats/min;
6. Serum cortisol concentration was normal or abnormal but not clinically significant according to the investigator's judgment;
7. Able to understand the procedures and methods of this study, willing to sign the informed consent and strictly abide by the trial protocol to complete the study.

Exclusion Criteria

1. patients requiring complex endoscopic techniques (such as cholangiopancreatography, endoscopic ultrasonography, endoscopic mucosal resection, endoscopic submucosal dissection, peroral endoscopic myotomy, etc.) or undergoing tracheal intubation;
2. patients with possible gastroduodenal outflow obstruction with retention of contents or upper gastrointestinal bleeding;
3. patients who were known or suspected to have allergies or contraindications to the components of the investigational drug or the prescribed regimen, or who were suspected to have epilepsy or severe liver and kidney dysfunction;
4. predicted difficulty in intubation or ventilation (e.g., modified Mallampti score Ⅲ-Ⅳ, congenital microglossia, mandibular hypoplasia, etc.);
5. having any of the following respiratory management risks before/at the time of screening: 1) history of asthma, wheezing; 2) sleep apnea syndrome;
6. QTcF≥450 ms (male) or ≥470 ms (female) at screening and confirmed by review; Or clinically significant electrocardiographic abnormalities that were deemed by the investigator to be ineligible for the study;
7. use of any of the following drugs or treatments before screening:1) enrolled in a clinical trial of any drug within 1 month before screening; 2) use of medications or treatments that affect cortical function within 3 days before screening; 3) Use of medications that may affect QT interval within 2 weeks before screening;
8. Laboratory tests during the screening period meet the following standards:1)AST and ALT ≥ 3×ULN;2)TBIL≥1.5×ULN;3)hemoglobin ≤90 g/L (and no blood transfusion within 14 days); 4)ANC≤1.5×109/L;5)platelet count ≤80×109/L;6)serum creatinine ≥1.5×ULN;
9. pregnant and lactating women; The reluctance of women or men of childbearing potential to use contraception for the entire dosing period; Subjects (including male subjects) who plan to become pregnant within 3 months after the trial;
10. Subjects with any other factors considered by the investigator to be ineligible for participation in the trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Etomidate group	Etomidate Injectable Product 0.3mg/kg group	0.3mg/kg
ET-26 0.6 mg group	ET-26HCl 0.6mg/kg group	0.6mg/kg
ET-26 0.8mg group	ET-26HCl 0.8mg/kg group	0.8mg/kg

Primary Outcome Measures

Name	Time	Method
Success rate of gastroscopy/colonoscopy	within approximately 15minutes after injection	Number of appends ≤5; No alternative medications or other sedatives/anesthetics were used from the beginning of the first dose of the trial product until the completion of gastroscopy/colonoscopy.

Secondary Outcome Measures

Name	Time	Method
Sedation/anesthesia success rate	Within approximately 1 minute of the end of the injection	Percentage of subjects with a MOAA/S score ≤1 after initial dosing of the investigational drug
Test drug additions	within 30minutes after injection	the additional situation and dosage of drugs were summarized
Cognitive function evaluation	Maximum 40 minutes after awakening	Mini-mental State Examination
Duration of successful sedation/anesthesia	within approximately 1minute after injection	The time from the first administration of the experimental drug to the MOAA/S score ≤1
Insertion duration	within approximately 7minutes after the first injection	The time between initial administration of the investigational drug and successful insertion of the lens
Success rate of lens insertion	within approximately 7minutes after the last injection	Percentage of subjects with successful insertion
Duration from completion of experimental drug administration to full recovery	Within approximately 30 minutes of the completion of the last injection	The time between the completion of the last trial drug administration and the subject's full recovery (the first of three consecutive MOAA/S scores of 5)
The time from the end of treatment to full consciousness	Within approximately 30 minutes of the completion of the first injection	The time from gastroscopy/colonoscopy withdrawal until the subject is fully awake (the first of three consecutive MOAA/S scores of 5)
Duration from the end of treatment to the end of the room	A maximum of 10 minutes after awakening	The first occurrence time from gastroscopy/colonoscopy withdrawal to 3 consecutive departures with Aldrete score ≥9
The time when BIS reaches 60 or below	within approximately 5minutes after injection	The period from the beginning of first dosing of the investigational product to the first BIS of 60 or less
The length of BIS between 40 and 60	within 7minutes after injection	Duration of BIS values between 40 and 60, including boundary values
Rate of use of remedial drugs	within 60minutes after injection	Percentage of subjects who had used the sedative/anesthetic remedy propofol injection once or more

Trial Locations

Locations (1)

Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital; 🇨🇳 Chengdu, Sichuan, China